MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	S-55-060-120-P6
Medical Device Problem Codes	Material Separation (1562); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat the superficial femoral artery (sfa).A 5x100 mm supera self expanding stent (ses) was implanted in the distal sfa with no issues and then a non-abbott ses was implanted as well.When attempting to deploy the 5.5x60 mm supera ses, the stent could not be released as it was stuck in the delivery system.The stent was removed with the delivery system still attached.There were no reported adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation/deployment failure was unable to be replicated in a testing environment due to the condition of the returned device.The reported material separation was able to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is possible that interactions with the anatomy and/or other devices resulted in the ratchet being unable to properly engage and release the stent from the delivery system resulting in reported activation/ deployment failure; however this cannot be confirmed.The investigation determined a conclusive cause for the reported activation/ deployment failure cannot be determined.Interaction/manipulation of the device during removal resulted in the reported tip separation/noted tip jacket and inner member separations.The noted multiple bends on the entire length of the catheter shaft and kink on the catheter shaft likely occurred due to handling (possibly contributing to the reported difficulties) or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Subsequent to the initially filed report, the following information was provided: the vessel diameter was 6.0 mm and atherectomy was not used.The lesion was prepared with a non-abbott 5x150 mm balloon at 8 atmospheres for 3 minutes.The supera partially deployed and was removed with the delivery system.Returned device analysis identified that the tip was separated and not returned.The account confirmed the tip separated upon removal and was discarded.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15242837
• Report Number: 2024168-2022-08840
• Device Sequence Number: 14639677
• Product Code: NIP
• UDI-Device Identifier: 08717648226083
• UDI-Public: 08717648226083
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: S-55-060-120-P6
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 2060461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5X100 SUPERA STENT; 7X100 EVERFLEX STENT
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 120 KG